Effect of Prevention Education in Caries Formation in Pediatric Patients With Leukemia

NCT03281746 | Terminated

• 2 other identifiers: MCC-16-13019NCI-2017-01354
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized pilot clinical trial studies how well preventive education works in decreasing caries formation in pediatric patients with leukemia. Prevention education may have an effect on factors important in causing cavities in pediatric patients with leukemia.

Conditions

Leukemia

Outcome Measures

Primary Outcomes (5)

• Change in caries assessed by CAMBRA risk assessment tool

  Baseline up to 32 weeks

• Change in salivary flow rate

  Change in salivary flow rate will be measured utilizing pre-weighed cotton rolls. Patients will saturate as many cotton rolls as possible in one minute by chewing. Dose cups and cotton rolls will be weighed prior to and after data collection. The change in weight in grams will be converted to mL of saliva collected.

  Baseline up to 32 weeks

• Change in salivary pH

  Will be measured with litmus paper in the gingival sulcus of the tooth where plaque is collected for bacterial load testing.

  Baseline up to 32 weeks

• Change in levels of mutans streptococci in buccal surface of most posterior maxillary right tooth

  Samples will be plated on mitis salivarius and incubated. Mutans streptococci colonies will be counted after incubation.

  Baseline up to 32 weeks

• Change in caries assessed by Merged International Caries Detection and Assessment System (ICDAS)

  Baseline up to 32 weeks

Study Arms (2)

Group I (standard prevention education)

ACTIVE COMPARATOR

Patients undergo dental examination at baseline and then receive standard prevention education at diagnosis discussing the effects of prolonged neutropenia on oral hygiene, importance of a regular oral hygiene regimen, and the long term clinical outcomes of oncologic patients. Patients also receive fliers with pictograms describing proper brushing, use of mouth wash, and common oral complications during therapy, as well as a bottle and prescription for chlorhexidine gluconate 0.12% rinse.

Procedure: Dental Procedure; Other: Educational Intervention (prevention education); Other: Interview; Other: Survey Administration

Group II (standard and one-on-one education, consultation)

EXPERIMENTAL

Patients undergo dental examination and receive standard prevention education as in Group I. Patients also receive one-on-one prevention education and counseling with the physician and pediatric dental resident.

Procedure: Dental Procedure; Other: Educational Intervention (prevention education); Other: Interview; Other: Survey Administration; Other: Educational Intervention (one-on one education)

Interventions

Dental Procedure PROCEDURE

Undergo dental examination

Group I (standard prevention education); Group II (standard and one-on-one education, consultation)

Educational Intervention (prevention education) OTHER

Receive prevention education

Also known as: Education for Intervention, Intervention by Education

Group I (standard prevention education); Group II (standard and one-on-one education, consultation)

Interview OTHER

Ancillary studies

Group I (standard prevention education); Group II (standard and one-on-one education, consultation)

Survey Administration OTHER

Ancillary studies

Group I (standard prevention education); Group II (standard and one-on-one education, consultation)

Educational Intervention (one-on one education) OTHER

Receive one-on-one education

Also known as: Education for Intervention, Educational Intervention, Intervention by Education, Intervention through Education

Group II (standard and one-on-one education, consultation)

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients who have been recently diagnosed with leukemia
• Patients will also predictably be in primary or mixed dentition
• Patients of Virginia Commonwealth University Medical Center Pediatric Hematology Oncology Clinic

You may not qualify if:

• Full permanent dentition
• Primary language is not English
• Children in the custody of the state with no parent or legal guardian present to sign consent

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Leukemia

Interventions

Dental Care; Educational Status; Methods; Interviews as Topic; Early Intervention, Educational

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Dentistry; Dental Health Services; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Child Health Services; Community Health Services; Preventive Health Services

Study Officials

• Helou A Marieka, MD, MPH

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 13, 2017
• Study Start: May 19, 2017
• Primary Completion: March 2, 2018
• Study Completion: March 2, 2018
• Last Updated: February 25, 2020

Record last verified: 2020-02

Locations

US (1)